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NCT01970527 · ClinicalTrials.gov registry record · Phase 2
Phase II Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Treating Patients With Stage IV Melanoma
A Phase 2 study, sponsored by University of Washington.
- Terminated
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT01970527: Clinical Trial Phase 2 study, sponsored by University of Washington.
NCT01970527 is a Phase 2 study that was terminated before completion, run by University of Washington. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01970527, a Phase 2 study, was terminated before completion, sponsored by University of Washington.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
This phase II trial studies how well stereotactic body radiotherapy and ipilimumab work in treating patients with stage IV melanoma. Stereotactic body radiotherapy (SBRT) may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Monoclonal antibodies, such as ipilimumab, target certain cells to interfere with the ability of tumor cells to grow and spread. Giving SBRT with ipilimumab may kill more tumor cells.
Primary Outcome
Scored on a non-index lesion using immune-related response criteria according to immune-related Response Evaluation Criteria in Solid Tumors version 1.1. The number of immune-related responses will be tabled by stratum and SBRT fraction dose level. At the MTD, the immune-related response rate and 95% exact confidence interval will be estimated separately for previously untreated and previously treated metastatic patients.
Interventions
- RADIATION Stereotactic Body Radiation Therapy
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Ipilimumab
- OTHER Pharmacological Study
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2014-03 |
| Est. Completion | 2019-06-21 |
| Phase | Phase 2 |
Why NCT01970527 stopped before completion
NCT01970527 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 4 interventions - of which Stereotactic Body Radiation Therapy is the first listed.
NCT01970527 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01970527 about?
NCT01970527 is a clinical study titled "Phase II Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Treating Patients With Stage IV Melanoma". This phase II trial studies how well stereotactic body radiotherapy and ipilimumab work in treating patients with stage IV melanoma. Stereotactic body radiotherapy (SBRT) may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Monoclonal antibodies, such as ipilimuma...
What is the current status of trial NCT01970527?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2014-03. Estimated completion is 2019-06-21.
What interventions are being tested in trial NCT01970527?
The interventions under investigation include: Stereotactic Body Radiation Therapy (RADIATION), Laboratory Biomarker Analysis (OTHER), Ipilimumab (BIOLOGICAL), Pharmacological Study (OTHER).
Who is sponsoring clinical trial NCT01970527?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01970527's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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